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Quality Assurance Engineer
Accepting applicationsZOLL Medical Corporation · Pawtucket, RI
Full-Time Mid_senior aiarmateganrf
Posted
6d ago
Category
Test
Experience
Mid_senior
Country
United States
Acute Care Technology
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won’t just have a job. You'll have a career—and a purpose.
Join our team. It’s a great time to be a part of ZOLL!
Job Summary
Responsible for supporting the Quality Assurance organization with quality improvement, supporting manufacturing, troubleshooting quality issues and monitoring quality trends; and interfacing with R&D to support new product introductions. Primary responsibilities are to prepare and maintain necessary documentation, monitor production quality performance to identify opportunities for improvements, act as a liaison between manufacturing and quality to promote quality awareness.
Essential Functions
Collaborate across functions, demonstrating quality and manufacturing expertise to solve problems, interpret data, and determine next steps.
Lead product complaint investigations, driving completion from receipt to resolution
Complete health risk assessments from product complaints or internal product/process/system issues
Develop and implement quality improvement programs
Support planning, review and approval of manufacturing process validations
Participate in change control activities for documents, manufacturing and QA/QC
Provide technical guidance to QA and QC personnel
Represent quality interests and concerns on project teams
Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements
Collect, analyze and disseminate quality data throughout the organization
Participate in Material Review Board activities, including resolution of product nonconformities
Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements
Participate in Risk Management activities
Monitor production quality performance to identify opportunities for improvements
Engage and interface in internal and external audits providing subject matter expertise.
Participate in the CAPA program as a trained CAPA lead
Other duties as assigned
Required/Preferred Education And Experience
Requires a BS degree; science or engineering related discipline
3+ years related experience in a regulated environment, preferably medical device
Proficient at problem solving
Excellent verbal & written communication skills.
Familiar with Statistical Analysis
Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices
Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
ASQ Certified Quality Engineer desirable
Knowledge, Skills And Abilities
Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.
Working Conditions
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet.
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
The Annual Salary For This Position Is
$75,000.00 to $95,000.00
This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
Show more Show less
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won’t just have a job. You'll have a career—and a purpose.
Join our team. It’s a great time to be a part of ZOLL!
Job Summary
Responsible for supporting the Quality Assurance organization with quality improvement, supporting manufacturing, troubleshooting quality issues and monitoring quality trends; and interfacing with R&D to support new product introductions. Primary responsibilities are to prepare and maintain necessary documentation, monitor production quality performance to identify opportunities for improvements, act as a liaison between manufacturing and quality to promote quality awareness.
Essential Functions
Collaborate across functions, demonstrating quality and manufacturing expertise to solve problems, interpret data, and determine next steps.
Lead product complaint investigations, driving completion from receipt to resolution
Complete health risk assessments from product complaints or internal product/process/system issues
Develop and implement quality improvement programs
Support planning, review and approval of manufacturing process validations
Participate in change control activities for documents, manufacturing and QA/QC
Provide technical guidance to QA and QC personnel
Represent quality interests and concerns on project teams
Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements
Collect, analyze and disseminate quality data throughout the organization
Participate in Material Review Board activities, including resolution of product nonconformities
Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements
Participate in Risk Management activities
Monitor production quality performance to identify opportunities for improvements
Engage and interface in internal and external audits providing subject matter expertise.
Participate in the CAPA program as a trained CAPA lead
Other duties as assigned
Required/Preferred Education And Experience
Requires a BS degree; science or engineering related discipline
3+ years related experience in a regulated environment, preferably medical device
Proficient at problem solving
Excellent verbal & written communication skills.
Familiar with Statistical Analysis
Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices
Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
ASQ Certified Quality Engineer desirable
Knowledge, Skills And Abilities
Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.
Working Conditions
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet.
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
The Annual Salary For This Position Is
$75,000.00 to $95,000.00
This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
Show more Show less